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RULES AND REGULATIONS

Title 28--HEALTH
AND SAFETY

DEPARTMENT OF HEALTH

[ 28 PA. CODE CHS. 101 AND 117 ]

Sexual Assault Victim Emergency Services

[38 Pa.B. 573]
[Saturday, January 26, 2008]

   The Department of Health (Department), following consultation with the Health Policy Board, amends Chapters 101 and 117 (relating to general information; and emergency services). The amended regulations are set forth in Annex A.

A.  Scope and Purpose of the Rulemaking

   This final-form rulemaking amends Chapter 117 to add minimum requirements for the physical and psychological treatment of sexual assault victims by hospitals of this Commonwealth. Although most hospitals currently provide medical services to sexual assault victims, there are no standard requirements for what services must be provided. This final-form rulemaking provides minimum requirements to be observed by all hospitals for ''sexual assault emergency services,'' which include services related to assessment and prophylactic treatment of sexually transmitted diseases, counseling regarding the assault either onsite or at a rape crisis center, and information and services related to emergency contraception. Further, this final-form rulemaking takes into consideration the needs of law enforcement in protecting the community by making evidence gathering easier and more consistent, and helping in the prosecution of sex crimes.

   This final-form rulemaking includes an exemption from requirements relating to the provision of emergency contraception services for hospitals that believe provision of that particular service would be contrary to the stated religious and moral beliefs of the hospital. This final-form rulemaking also provides that hospitals currently offering the most limited range of services and electing to refer all emergency patients after institution of essential life-saving measures may also elect not to provide any sexual assault emergency services. These hospitals will be required to comply with certain notice and transport provisions.

   The Department published notice of the proposed rulemaking at 36 Pa.B. 6403 (October 21, 2006) and provided a 30-day public comment period.

   The Department received comments from a variety of commentators including insurers, advocacy groups, professionals and religious organizations. The Department also received comments from the Independent Regulatory Review Commission (IRRC). The comments and the Department's responses to them appear in the summary of this final-form rulemaking.

B.  Summary

General Comments and Revisions

   In addition to comments on specific sections of the regulations discussed, the Department received some general comments as follows.

   IRRC suggested the Department provide additional information regarding the need for these regulations, including quantifying the number of victims who did not receive the appropriate and necessary care and services. Unfortunately, for a variety of reasons, many sexual assaults go unreported and victims are less likely to seek treatment for injuries related to a sexual assault than for injuries related to other crimes. A 2001 report from The Center for Sex Offender Management (a collaborative effort of the Office of Justice Programs, the National Institute of Corrections, and the State Justice Institute administered by the Center for Effective Public Policy and the American Probation and Parole Association), included statistics from the National Crime Victimization Surveys (Bureau of Justice Statistics) conducted in 1994, 1995 and 1998. These studies indicated that only 32% of sexual assaults against persons 12 or older are reported to law enforcement. A separate 3-year longitudinal study of 4,008 adult women found that 84% of respondents who identified themselves as sexual assault victims did not report the crime to authorities. Because of this underreporting, it is not possible for the Department to accurately quantify some of the information requested by IRRC.

   However, research conducted by the ACLU and the Clara Bell Duvall Reproductive Freedom Project indicate that approximately 48% of hospitals in this Commonwealth provide emergency contraception to female sexual assault victims on a regular basis. Almost 35% of the hospitals surveyed had some emergency contraception policy, but it varied and was unclear. This final-form rulemaking seeks to ensure increased access to appropriate medical and psychological treatment for sexual assault victims by standardizing the policies and procedures which hospitals develop for treatment of sexual assault victims. Proper implementation of this final-form rulemaking will significantly increase the number of hospitals that provide emergency contraception on a regular basis, and eliminate any uncertainty as to established procedures which may currently exist.

   One commentator noted the regulations do not address issues regarding parental consent for minors. Currently, the laws of the Commonwealth recognize that minors may individually consent to certain medical treatment or services that pertain to reproductive health and rights. See, Parents united for Better Schools, Inc. v. School District of Philadelphia Board of Education, 978 F.Supp. 197 (E.D. Pa. 1997); Carey v. Population Services International, 431 U.S. 678 (1977); Planned Parenthood v. Danforth, 428 U.S. 52 (1976); 42 U.S.C. § 300 et seq.; 42 U.S.C. § 1396(a)(10)(A); and section 3 of the act of February 13, 1970 (P. L. 19, No. 10) (35 P. S. § 10103). This includes the right to obtain emergency contraception without parental consent, and over the objections of a parent or guardian. A minor may also refuse to take emergency contraception notwithstanding a parent or guardian's insistence that the medication be provided. A reference card which includes information regarding a minor's right to obtain emergency contraception and many of the other services required by these regulations has been developed by several groups, including the Children's Hospital of Philadelphia, Children's Hospital of Pittsburgh, Penn State Children's Hospital, St. Christopher's Hospital for Children, the ACLU of Pennsylvania and Physicians for Reproductive Choice and Health. This card can be located online at www.aclupa.org/downloads/PAminorscard2005.pdf, or www.prch.org/med_ed/minors_ rights/Penn.pdf. As information regarding the rights of minors to obtain the necessary treatment for a sexual assault is readily available, the Department has decided not to include additional information in the final-form rulemaking.

   Another commentator noted that Plan B, an emergency contraception drug, is now available over-the-counter for individuals 18 or older. The commentator questioned the need for this rulemaking in light of these developments. The Department is aware that even prior to the Food and Drug Administration's (FDA) approval of Plan B as an over-the-counter drug, sexual assault victims could obtain emergency contraception by prescription at many local pharmacies, clinics, physicians offices and at some hospitals which had developed procedures for treating sexual assault victims. However, the goal of these regulations is to ensure a victim receives full and adequate care at one location. Therefore the Department has made no revisions to the regulations.

   One commentator suggested the Department seek to have funds made available for increased Sexual Assault Nurse Examiner, Sexual Assault Forensic Examiner and Sexual Assault Response Team training. Although the Department hopes these regulations will encourage practitioners to seek this training and for hospitals and local government and law enforcement authorities to encourage this training, the Department is not able at this time to provide funding. However, the information available to the Department about this training shows it is not cost prohibitive for hospitals or practitioners to seek the training as a means to increase their awareness of the appropriate treatment of sexual assault victims and provide the highest level of services possible for their communities.

   The Department has also made other minor and nonsubstantive revisions to the regulations. These revisions correct grammatical or spelling errors or make more appropriate reference to provisions which were not properly identified in the proposed regulations.

Section 101.4. Definitions.

   One commentator suggested the Department amend the definition of ''emergency contraception'' to mirror that in Senate Bill 990 of the 2005-2006 Pennsylvania Legislative Session (PN 2109), the Compassionate Assistance for Rape Emergencies Act (SB 990). The commentator argued that the definition proposed by the Department might prohibit some hospitals from providing emergency contraception, because interfering with the implantation of a fertilized ovum within the uterus may be contrary to the religious or moral beliefs of these hospitals. The definition in SB 990 had been revised to exclude the phrase ''implantation of a fertilized ovum within the uterus.'' Although the Department did not adopt the suggested definition, it has revised the definition in a manner it believes addresses the concerns of the commentators.

   Although none of the comments received indicated that the commentators were confused about the difference between emergency contraception and mifepristone, it is important to distinguish the two here for clarification. The most recognized brand name for emergency contraception, Plan B, contains levonorgestrel, a synthetic version of the hormone progestin. By taking two pills within the time period specific by the manufacturer, levonorgestrel can prevent pregnancy. Levonorgestrel primarily acts by stopping ovulation, that is, the release of an egg from the ovary. It may also inhibit or prevent fertilization if an egg has already been released, or inhibit or prevent the implantation of a fertilized egg within the uterus. If a fertilized egg is implanted before taking levonorgestrel, the drug will not be effective.

   Mifepristone, often referred to as RU-486, is a synthetic steroid compound which is used as an abortifacient in the first 2 months of pregnancy. Unlike emergency contraception which is only effective before pregnancy, mifepristone has the effect of a medical abortion. To be clear, the Department is not sanctioning the use of mifepristone by this final-form rulemaking and, due to the fact that it would have the effect of causing the termination of an existing pregnancy, the use of mifepristone is governed by separate provisions of law. Furthermore, although some studies have indicated that a 10 mg dose of mifepristone may have contraceptive effects of preventing ovulation, the smallest dose approved by the FDA at this time is 200 mg. As a result, under current approvals, mifepristone could not be used as emergency contraception under this final-form rulemaking.

   Some commentators suggested revisions to the definitions of ''rape crisis center'' and ''sexual assault counselor.'' IRRC also suggested a revision to the definition of ''sexual assault counselor,'' and inquired as to the training requirement in the definition. The Department has not changed the proposed rulemaking in response to these comments. For both of these terms, the Department utilized the definitions currently existing in 42 Pa.C.S. § 5945.1 (relating to confidential communications to sexual assault counselors). This section of the Pennsylvania Consolidated Statutes creates the confidentiality of communications between victims and sexual assault counselors. The Department will keep the definitions as proposed to ensure hospitals refer victims to the appropriate individuals and locations, and that the statutory confidentiality is preserved.

   One commentator also suggested the term ''sexual assault'' and its definition, as presented in the proposed regulations, may be considered limited to just those crimes included under the term ''sexual assault'' as defined in 18 Pa.C.S. § 3124.1 (relating to sexual assault). Because the term ''sexual assault'' is generally understood to include various sex crimes, as is evidenced by the term ''sexual assault counselor'' in 42 Pa.C.S. § 5945.1, the Department decided to retain this term. The term ''sexual assault'' was also used in SB 990, and is found in legislation recently enacted in the Commonwealth, the Sexual Assault Testing and Evidence Collection Act (35 P. S. §§ 10172.1--10172.4). Although the Department has retained the term ''sexual assault'' in this final-form rulemaking, the definition has been revised to more clearly indicate that all crimes defined in 18 Pa.C.S. Chapter 31, Subchapter B (relating to definition of offenses) except indecent exposure as defined in 18 Pa.C.S. § 3127 (relating to indecent exposure) and sexual intercourse with an animal as defined in 18 Pa.C.S. § 3129 (relating to sexual intercourse with animal), are included in the regulation's definition of ''sexual assault.''

   In a comment related to the issue of the use of the term ''sexual assault,'' some commentators, including IRRC, recommended the Department consider changing to the term ''sexual assault victim'' and definition of that term. This comment was based on the possibility that the Department would revise the term ''sexual assault'' under the previous comments. Because of the revisions to the definition of ''sexual assault'' and the other reasons previously listed, no revisions to this term or its definition are necessary.

§ 117.15.  Community-based plan.

§ 117.41.  Emergency patient care.

   Although these sections of the existing Department regulations relating to emergency services in hospitals were not included in the proposed rulemaking, IRRC suggested that the Department revise the proposed rulemaking or existing provisions in Chapter 117 to resolve inconsistencies between the use of the terms ''rape'' currently existing in § 117.15(b)(4)(iii) and (9) and the term ''sexual assault'' as included in the proposed rulemaking. In response to these suggestions, the Department has revised § 117.15(b)(4)(iii) and (9) to replace the term ''rape'' with ''sexual assault.'' This change does not alter the intent or reading of these existing provisions and in fact assists in providing a clearer understanding as to their applicability.

Sexual Assault Victim Emergency Services

Section 117.51. Scope.

   As a result of the following changes, the Department has renamed this section from ''Principle'' to ''Scope'' to more accurately describe its purpose in this final-form rulemaking.

   IRRC questioned the need for this section of the regulations, stating that the section appeared to serve as a ''table of contents'' for the other provisions in the proposed rulemaking, and did not add any substantive material to it. In response to this comment, and as a result of changes made to other sections of the regulations as discussed in more detail as follows, § 117.51 has been revised to more clearly establish its purpose of identifying which hospitals are subject to this final-form rulemaking.

   Some commentators requested the Department remove any language that allowed facilities to elect not to provide any sexual assault emergency services pursuant to the exemption provisions of § 117.58 (relating to exemption for hospitals providing limited emergency services). Alternatively some commentators suggested the Department clarify the language in this section to require all hospitals proficient in providing these services to be required to do so. As these comments are more specifically related to the exemption provisions of § 117.58, the Department has included its response to the comments to § 117.58.

   One commentator suggested the Department include language indicating the specific governmental interest in the promulgation of this final-form rulemaking. The statement is not appropriate for the regulations as it does not direct facility conduct or set a regulatory standard under which the Department's surveyors can review a facility for compliance. However, the governmental interest for promulgating this final-form rulemaking was discussed in the preamble published with the proposed regulations, and is also discussed throughout this preamble.

Section 117.52. Minimum requirements for sexual assault emergency services.

   Most of the commentators commended the Department on the establishment of comprehensive minimum guidelines for the treatment of sexual assault victims in proposed § 117.52. However, some commentators did make comments and suggestions.

   One commentator suggested this final-form rulemaking be more explicit as to the type of evidence that must be collected under the provisions of proposed § 117.52(a)(1). The commentator also suggested the Department mention the use of rape kits in this section. IRRC agreed with these comments. Following the publishing of proposed rulemaking by the Department, the Sexual Assault Testing and Evidence Collection Act (35 P. S. §§ 10172.1--10172.4) was enacted, requiring the Department to administer a Statewide sexual assault evidence collection program. As part of this program, the Department is to consult with the Pennsylvania Coalition Against Rape and the Pennsylvania State Police to develop minimum standard requirements for all rape kits used in hospitals and to test and approve commercially available rape kits for use in this Commonwealth. As a result of this legislation and in response to these comments, the Department has revised § 117.52(a)(1) to include a requirement that all hospitals providing sexual assault emergency services utilize the minimum standards and rape kits as approved by the Department under that act. A list of minimum standards for rape kits and rape kits approved by the Department under the Sexual Assault Testing and Evidence Collection Act will be published in the Pennsylvania Bulletin.

   One commentator recommended the Department revise proposed subsection (a)(1) to add ''as indicated by the history of the incident'' at the end of the paragraph. Due to the nature of a sexual assault, this information may not be available to a practitioner before the practitioner begins to provide services. Further, the Department does not wish to include language which may be read to limit the practitioner's ability to decide what information is important for determining the appropriate examinations and tests which should be conducted. Accordingly, the Department has decided not to include the suggested language.

   Another commentator suggested specific revisions to the requirements in proposed subsection (a) to create a more general requirement of diagnostic testing and treatment as deemed appropriate by the physician, and eliminating some of the more specific requirements in proposed subsection (a)(4)--(6). Due to the overwhelming comments commending the Department for its comprehensive approach to treatment of sexual assault victims, including the specific provisions in this section, the Department has retained the language included in the proposed regulations. Based on these and other comments, however, the Department has revised the language of proposed subsection (a)(5) to make it clear that a determination of the necessary testing is left to the professional judgment of the examining practitioner based on the practitioner's assessment of the victim's condition.

   Another commentator recommended the Department specify that a hospital is only required to provide a victim with the initial dosage of STD or HIV prophylaxis and to give the victim information on how to obtain the rest of the recommended regimen, if any. Similar comments were received in response to proposed § 117.54 (relating to prevention of sexually transmitted diseases). This comment is addressed as follows along with the comments received in response to proposed § 117.54, and revisions have been made accordingly.

   Three commentators also recommended that the Department revise the regulations to require hospitals to contact a rape crisis center or sexual assault counselor immediately upon a sexual assault victim presenting at the facility. Those commentators indicated the rape crisis center or sexual assault counselor could then advise the sexual assault victim about the services they offer and provide other counseling and information regarding treatment of the sexual assault. Although the Department believes contact with a rape crisis center or sexual assault counselor would be of great assistance to sexual assault victims, the sexual assault victim should have the ability to decide whether a center or counselor will be contacted both to protect the privacy of the victim and to allow the victim to make an informed decision about the extent of the treatment the victim wishes to receive. Based on their experience, hospitals and their practitioners could inform the sexual assault victim of the benefits of speaking with a rape crisis center or sexual assault counselor. The Department has, however, revised subsection (a)(7) to require prompt notification of a rape crisis center or sexual assault counselor if the victim makes that request.

   Two commentators suggested that the Department include a requirement for the provision of emergency contraception in this section to clearly indicate its importance in the appropriate treatment of female sexual assault victims. Similar comments were received in response to proposed § 117.53 (relating to emergency contraception). Although the Department believes the regulations do sufficiently identify the importance of emergency contraception, language has been added to this section in subsection (a)(9) to address the commentators' concerns.

   Some commentators suggested the Department establish certain minimum training standards that physicians and nurses who treat sexual assault victims must meet. Another commentator recommended that the Department require that hospitals staff their facilities with Sexual Assault Nurse Examiners or Sexual Assault Forensic Examiners, or that the hospitals work with Sexual Assault Response Teams to perform evaluations and treatment and to conduct evidence collection. IRRC also made a similar suggestion. While the Department would encourage hospitals to utilize the most appropriately trained staff to provide the services required by this final-form rulemaking, the Department believes hospitals and their staff are best suited to determine the appropriate training for practitioners treating sexual assault victims under this final-form rulemaking.

   IRRC inquired as to how the requirements in subsection (a) are to be balanced with other potential acute care needs of a sexual assault victim. IRRC also submitted similar comments in response to proposed §§ 117.57 and 117.58 (relating to religious and moral exemptions; and exemption for hospitals providing limited emergency services). The Department is cognizant of the fact that a sexual assault victim may present at a hospital with other physical injuries from the sexual assault, some of which may take medical priority for treatment over the requirements of these regulations. To eliminate any concerns that the regulations may be read as taking priority over other medical care which may require more immediate attention, the Department has revised subsection (a) to require a hospital to provide the required services promptly, or as immediately thereafter as medically appropriate depending on the condition of the victim. A hospital shall also provide other services for treatment of the sexual assault as medically indicated by the condition of the victim, including treatment for any injuries or trauma resulting from a violent physical attack.

   IRRC also inquired as to the accessibility of medical records under these provisions. First, IRRC noted one commentator's concern that gathering information about the sexual assault and the victim and including it in the medical record may lead to its use against the victim in a court of law. Some commentators also noted the regulations do not speak directly to confidentiality or privacy. IRRC also questioned the accessibility of this information by others. Second, IRRC inquired as to the length of time a hospital is required to maintain medical records under this final-form rulemaking.

   As to the concerns for confidentiality and privacy, the Department notes confidentiality and privacy of medical information is currently addressed and protected by various provisions of law which must be adhered to by the facility and practitioners, including common law and statutory privileges like the doctor-patient privilege, Federal law like the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et. seq.; 45 CFR 160.101 (relating to statutory basis and purpose)) and State law like the Department's hospital regulations (Chapter 115 (relating to medical records services)). For example, § 115.27 (relating to confidentiality of medical records) provides for the confidentiality of medical records and procedures for their release. Hospitals and practitioners would be required to maintain any confidentiality or privileges provided in State and Federal law. Similarly, nothing in these regulations conflicts or supersedes the provisions of the ''Rape Shield Law,'' 18 Pa.C.S. § 3104(a) (relating to evidence of victim's sexual conduct), which provides for the inadmissibility of evidence of a sexual assault victim's past sexual conduct in criminal proceedings.

   With regards to the length of time medical records must be maintained, the Department notes its regulations, as they appear in Chapter 115, already address issues relating to medical records in hospitals. Specifically, § 115.23 (relating to preservation of medical records) provides the time periods for the retention of records. To ensure hospitals are aware of the requirement to maintain these records in a manner consistent with the provisions in Chapter 115, the Department has revised subsection (b) of this section to include reference to this chapter.

Section 117.53. Emergency contraception.

   The Department received a comment requesting that it remove any specific requirement that the hospital provide a female sexual assault victim with emergency contraception. The commentator argued the language was unnecessary and that individual practitioners should determine which medication would be appropriate for the victim. As recent events in this Commonwealth have demonstrated that at least one hospital did not include emergency contraception in the policies and procedures for treating sexual assault victims, the Department believes specific language requiring hospitals to provide emergency contraception is appropriate, and has not revised the regulations.

   The Department received several comments on the requirements for the oral and written emergency contraception information that must be provided by hospitals to sexual assault victims contained in proposed subsection (a)(1) and (2). The Department has addressed those comments in its discussion of § 117.55 (relating to emergency contraception informational materials).

   The Department also received comments requesting the regulations specify that the oral information about emergency contraception hospitals give to sexual assault victims also be objective and medically and factually accurate. The requirement of paragraph (2), formerly proposed subsection (a)(2), that hospitals provide oral information goes beyond that of the written information materials, which only requires the hospital provide the materials to the victim without further explanation or information regarding the availability of emergency contraception. This provision requires hospitals to inform the victim of the fact that emergency contraception is available at the hospital and to explain its use, risks and efficacy. This requirement, and other requirements in §§ 117.52(a), 117.54 and 117.56 (relating to minimum services for sexual assault emergency services; prevention of sexually transmitted diseases; and information regarding payment for sexual assault emergency services) will assist in opening a dialogue between the hospital and the victim to ensure that the victim is fully informed of the available treatment for the sexual assault. Information provided by a hospital to a patient is required by other provisions of law to be medically and factually accurate, and as such, including that requirement here is unnecessary. The Department has added language to require that, at a minimum, the oral information about emergency contraception required by the regulations be objective.

   Several commentators recommended revisions to the language in proposed subsection (b) regarding pregnancy testing prior to the provision of emergency contraception to female sexual assault victims. One commentator also suggested the Department broaden the language to include ovulation testing in order to allow certain hospitals to exercise moral conscience. Other commentators requested that the Department limit the ability of a facility to conduct a pregnancy test or to condition providing emergency contraception on a pregnancy test. Some commentators suggested language regarding pregnancy tests be eliminated altogether. IRRC also questioned the need for this provision, considering emergency contraception will have no effect in eliminating an existing pregnancy. IRRC commented, however, that if pregnancy is a contraindication of emergency contraception this should be specifically mentioned in the regulations.

   Having considered all these comments, the Department has removed proposed subsection (b) to eliminate any of the potential problems raised by the commentators, and has renumbered the section accordingly. A hospital or practitioner may choose to exercise conscience without a regulation from the Department. Although pregnancy is a contraindication for the administration of emergency contraception, hospitals and health care practitioners should exercise professional judgment in informing sexual assault victims about the contraindications of medications and treatment available to the victim. Accordingly, the Department has clarified paragraph (3) to indicate that emergency contraception must be provided unless medically contraindicated or unless the hospital is operating under the religious or moral exemption of § 117.57.

Section 117.54. Prevention of sexually transmitted diseases.

   One commentator suggested the Department eliminate this section entirely, and instead create and provide written informational materials which could be used by the victim to determine the treatment they wish to receive. While the Department is charged with promoting the health, safety and adequate care of residents in healthcare facilities in this Commonwealth, it is not appropriate for the Department to supplant the role of healthcare providers and practitioners in providing appropriate medical information and treatment to individuals. Substituting the compassionate care which is offered by health care providers and health care practitioners in this Commonwealth with written informational materials may be viewed as inappropriate, especially for an individual who presents at a hospital as the victim of a traumatic event such as a sexual assault. The Department has, therefore, retained this section with certain revisions as described as follows.

   Two commentators requested the Department delete the phrase ''significantly prevalent'' as it appeared in subsections (a) and (c). The commentators also suggested the Department add ''including Hepatitis and HIV'' to these subsections. As the hospital providing treatment to a victim is best able to determine which tests and treatments are appropriate, the Department has revised the regulations to incorporate these suggestions and allow hospitals more latitude in making these decisions.

   These commentators also suggested the Department delete ''and tests that may be conducted'' from proposed subsection (b)(1). The commentators included no explanation for this recommendation. The risk assessment required by subsection (a) would include consideration of results from tests which may be conducted by the hospital to ensure that a victim receives the appropriate treatment. The Department has not revised the proposed subsection in response to these comments.

   Some commentators suggested the Department clarify the requirement that hospitals provide STD prophylaxis to indicate that only an initial 72-hour dosage be provided, with the hospitals providing the victim information and the means, such as prescriptions, for obtaining the remainder of the medication if it is deemed necessary. Although, based on risk assessment conducted by the hospital pursuant to the regulations, some victims may not need STD prophylaxis medication, in other instances certain findings of the risk assessment or the unavailability of some information needed to complete the risk assessment may necessitate a victim receiving at least the initial 72-hour dosage. During this 72-hour period, additional information may be obtained by the hospital which would allow it to inform the victim as to whether continuing with the full dosage is necessary. A victim should not be burdened with the expense and difficulty of continuing with a 30-day regimen of STD prophylaxis if it is determined the full regimen is unnecessary. The Department has revised the regulations to incorporate the commentators' suggestions.

   Some commentators asked who would be responsible for payment of the cost of STD prophylaxis and noted the potential high cost of this medication. The Department has included provisions in § 117.56 to require that hospitals inform victims of known resources for payment, including programs for the uninsured or underinsured. In fact, another commentator recommended the inclusion of text from 42 Pa.C.S. § 1726.1 (relating to forensic examination costs for sexual offences), which specifically provides that the ''cost of a forensic rape examination or other physical examination conducted for the purpose of gathering evidence in any criminal investigation and prosecution under 18 Pa.C.S. Chapter 31 (relating to sexual offenses) and the cost to provide medications prescribed to the victim therein shall not be charged to the victim. If appropriate insurance is unavailable, reimbursement may be sought pursuant to the provisions of section 477.9 of the act of April 9, 1929 (P. L. 177, No. 175), known as The Administrative Code of 1929.'' (42 Pa.C.S. § 1726.1.) The referenced section of The Administrative Code of 1929 provides for reimbursement by the Victims Compensation Assistance Program. Because of existing law, therefore, the Department believes no revisions are necessary to address this concern.

   IRRC recommended the Department include a more specific citation to the United States Department of Health and Human Services Centers for Disease Control and Prevention (CDC) risk assessment standards referenced in subsections (b) and (c). At the current time, the CDC includes its recommendations in a guidance document entitled ''Sexually Transmitted Diseases Treatment Guidelines, 2006.'' This document, and its recommendations, can currently be found at www.cdc.gov/std/treatment/default.htm. This document was also included in the August 4, 2006, edition of the CDC's Morbidity and Mortality Weekly Report. Centers for Disease Control and Prevention, Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006;55 (No. RR-11). However, as the Department is unable to predict when this document will be updated (previously the recommendations were included in ''Sexually Transmitted Diseases Treatment Guidelines, 2002'') or whether the recommendations will be incorporated into another CDC publication, the regulations do not include a specific document citation which may require constant revisions in the future. Hospitals and their staff should be capable of locating these guidelines for inclusion in their treatment policies and procedures and are likely already aware of these guidelines. Accordingly, no revisions have been made under IRRC's recommendations.

Section 117.55. Emergency contraception informational materials.

   One commentator suggested the Department eliminate this section, because the substance of this section is addressed in § 117.52 (relating to minimum requirements for sexual assault emergency services). This section, however, contains additional information not included in § 117.52, and it is necessary for implementation of the regulations. Therefore, the Department has not revised this section.

   Some commentators suggested the Department include more specific standards for the written informational materials, or review and approve the materials created by the hospitals. At least one commentator suggested the Department create the materials and make them available to hospitals. After considering these comments, the Department has revised § 117.55(b) to provide that the Department will develop the written emergency contraception informational materials and make them available to hospitals in electronic format. Hospitals, and the general public, will be able to obtain these materials from the Department's website or by requesting an electronic copy from the Department. Hospitals will be required to obtain the information materials, print them, and make them available to their staff and to sexual assault victims. This will ensure consistency in the information provided and reduce the cost to hospitals for compliance with these provisions.

   Another commentator suggested the Department produce a list of locations where emergency contraception can be obtained. Some commentators suggested the written emergency contraception informational materials include a list of locations where emergency contraception is available. Due to the Department's limitations, it is not possible to create individual documents for each hospital to use, identifying the locations nearest to each hospital where emergency contraception is available. Although the materials will not include a specific list of locations where emergency contraception is available, the materials will inform victims of its availability, including the requirements that certain hospitals provide emergency contraception to sexual assault victims. Further, the materials will include contact information for rape crisis centers, where victims can obtain additional assistance, including counseling and referral for emergency contraception.

   In contrast to the previous comments, one commentator suggested that requiring hospitals that exercise the religious or moral exemption provided under § 117.57 to refer victims to locations where emergency contraception can be obtained could constitute material cooperation by the hospital in an activity it finds contradicts with its stated religious or moral beliefs. The Department will be producing the written emergency contraception materials to be used by hospitals, so that this concern should no longer be an issue. Furthermore, the commentator noted that providing a victim with contact information for a rape crisis center would not violate the stated religious or moral beliefs with which this commentator was concerned. The materials prepared by the Department will not include a list of locations to obtain emergency contraception, but will provide a toll free number that a sexual assault victim can call to contact a local rape crisis center.

Section 117.56.  Payment for sexual assault emergency services.

   One commentator suggested this section was unnecessary because hospitals already provide patients with information on financial resources available to pay for services received. The commentator asked that this section be deleted. Several other commentators commended the Department on requiring this information be provided by hospitals. Although § 103.22(b)(18) and (19) (relating to implementation) do contain language similar to that in § 117.56, this section goes further in identifying some of the specific resources for payment, including, for example, the Victim Compensation Assistance Program administered by the Pennsylvania Commission on Crime and Delinquency. By including this section, the Department will be able to identify additional financial resources in the regulations as they become available. It is imperative that a sexual assault victim is properly informed of financial resources for payment of the care, to ensure that a victim does not refuse treatment based on a concern of the inability to pay for the services. IRRC also commented on this section, and stated that ''the regulations should require that victims receive comprehensive information on their financial responsibility and all resources available to them for covering the costs of their treatment.'' The Department agrees, and has accordingly retained this section of the regulations.

   Another commentator requested the Department include clarification about Medicaid and Medicare payment methods for these services. It is impractical for the Department to provide more specifics about these programs in its regulations, since they are currently operated by other agencies, and are subject to change before the Department has an opportunity to amend its regulations. To ensure the regulations will not require regular revisions, no revisions have been made in response to these comments. More information regarding the treatment or services covered by Medicaid or Medicare can be obtained from the agencies responsible for administering these programs.

   One commentator suggested the Department explore ways to reduce the cost of services to victims, such as working with drug manufacturers to lower medication costs. Although reducing costs of services and medications for sexual assault victims is certainly important, it would be inappropriate for the Department to engage in the negotiations and transactions required to accomplish these goals. However, there are several sexual assault victim advocacy groups in this Commonwealth that can negotiate with hospitals and drug manufacturers to achieve the same goals, and this is preferable to government intervention in cost of services or medication.

   One commentator suggested the Department more clearly state whether victims will be responsible for any costs associated with the provision of these services. Because the costs for services and payment methods for each sexual assault victim are unique, the Department cannot develop specific language to address each separate circumstance. The Department has not revised the regulations in response to the commentator's concerns.

   One commentator noted that sexual assault victims should be provided information to inform them that any applicable medical insurance company need not be notified of the fact the individual was the victim of a sexual assault. However, the commentator did not provide sufficient information for the Department to determine the specific circumstances under which this statement would apply. Further, the method by which a hospital or individual requests reimbursement from a health insurer, and the information that must be provided to the insurer in order for reimbursement to occur, are not within the Department's control. The Department has not revised the regulations in response to this comment.

Section 117.57.  Religious and moral exemptions.

   Some commentators suggested the Department include a religious and moral exemption for individual practitioners similar to that included in this section for hospitals. The Department has not revised the regulations in response to these comments. The Health Care Facilities Act (HCFA) (35 P. S. §§ 448.101--448.904a) provides the Department with the authority to license and regulate health care providers and facilities, not health care practitioners. The authority to license and regulate the health care practitioners who would provide the services in hospitals under the regulations is vested in the Department of State. A hospital should develop procedures that would assure the provision of sexual assault victim emergency services in accordance with the Department's regulations and yet still accommodate an individual practitioner's needs. Furthermore, the Department, through its regulations relating to civil rights (28 Pa. Code §§ 51.11--51.13 and 101.161--101.165 (relating to civil rights)), requires compliance with all civil rights laws with regards to the treatment of patients and facility personnel, and discrimination against a practitioner on the basis of religion is prohibited.

   Some commentators suggested that hospitals should not be provided a religious or moral exemption to the requirement that hospitals provide emergency contraception to sexual assault victims. The religious or moral exemption regarding the provisions of emergency contraception by hospitals is not created by the Department through its regulations. Instead, the regulations recognize the language of the HCFA, which creates the exemption, and provides for certain notification and transport provisions for hospitals eligible for and availing themselves of the exemption. Further, even if the HCFA did not provide the exemption, some stakeholders have argued that Pennsylvania's Religious Freedom Protection Act (RFPA) (71 P. S. §§ 2401--2407) would prohibit the Department from requiring certain hospitals to provide emergency contraception. As any exemption which may exist is a matter of statutory language enacted by the General Assembly, the Department cannot revise the regulations to address the commentators' concerns.

   One commentator suggested a facility's denial of emergency contraception could be considered discriminatory towards the victim and a violation of the sexual assault victim's constitutional and statutory rights. IRRC also submitted comments to the Department on this issue and asked that it be resolved in light of one commentator's concerns that requiring hospitals to provide emergency contraception may violate the RFPA. The Department has not been presented with any law or court ruling which would support the position that an individual has a religious or civil right to be provided a particular medication in a hospital. The Department is not in a position to make ultimate determinations on whether a hospital's refusal to provide emergency contraception would violate any rights conferred to the victim. A review is up to the applicable courts. However, the Department does enforce applicable law, and would reexamine the regulations if presented with sufficient legal authority to support the commentator's position.

   Some commentators suggested that, even if a hospital were able to avail itself of a religious or moral exemption to the requirement that the hospital provide emergency contraception to a sexual assault victim, the exemption should not be extended to the requirements in § 117.52(a)(2). That section states that a hospital must orally inform the victim of the availability of emergency contraception. Comments submitted by one commentator suggest that providing oral information regarding emergency contraception would not violate a facility's religious or moral beliefs. Having reviewed material regarding religious objection to providing emergency contraception, the Department agrees with these comments and it has revised the regulations to require all hospitals to provide oral information about emergency contraception.

   One commentator provided alternative language which, although similar to that in the proposed regulations, did not give reference to the HCFA, and did not ensure that arrangements would be made to arrange for transportation for a victim to a location that could provide emergency contraception. Although the Department appreciates comments which provide alternative language, the Department has not incorporated the language into this final-form rulemaking.

   Some commentators suggested the ''safeguards'' of the RFPA be incorporated into the regulations to ensure a hospital does not improperly claim a religious or moral exemption. Another commentator suggested a hospital should be required to apply to the Department for an exception to exercise a religious or moral belief. One commentator requested additional clarification on what constituted a ''religious'' hospital. IRRC similarly inquired as to what the Department would deem ''religious or moral beliefs.''

   Because the HCFA applies to all hospitals, where the RFPA only applies to those hospitals which fall within the RFPA's definition of ''person,'' the Department opted to make reference to the HCFA which is equally applicable to hospitals within the Department's regulatory authority. However, neither the HCFA nor RFPA grant the Department the authority to make determinations of the applicability of these laws to a hospital's stated religious or moral beliefs. Those determinations can be made by a court of law. Accordingly, the Department is only requiring that a hospital inform the Department of its intent to exercise the exemption in § 117.57, and provide it with documentation, reviewed and approved by the hospital's governing body, to confirm the hospital's stated religious or moral beliefs. The Department will review this notification to ensure a facility does in fact have a stated religious or moral belief against the provision of emergency contraception. It should be noted that the Pennsylvania Code currently provides for a similar arrangement with regards to a facility's stated ethical policy as it pertains to abortion or sterilization. (See 16 Pa. Code §§ 51.31--51.33 (relating to rights and obligations of hospitals and other health care facilities).)

   Another commentator argued the referral and transport provisions could violate a hospital's rights and the RFPA. The Department's regulations do not require referral of the victim to a facility where emergency contraception is provided, nor do they require transport by the hospital. As noted previously, the written emergency contraception informational materials will list a telephone number for a rape crisis center. This Center can make the appropriate referral of the victim to a location where emergency contraception can be obtained without the hospitals involvement. Further, a hospital is not required to actually transport the victim, but instead is required to arrange for transportation for the victim. This can be accomplished, and the regulations complied with, by having the hospital make arrangements with a local rape crisis center or other similar sexual assault victim assistance organization to provide transportation to the victim. The RFPA states that an agency shall not ''substantially burden the free exercise of religion without compelling justification.'' 71 P. S. § 2402(1). The Department does not believe that the regulations present a substantial burden to the free exercise of religion under the RFPA. Even if it could be argued that the regulations present a substantial burden to the free exercise of religion, they do so in furtherance of compelling interests of the Department and are the least restrictive means of furthering the interest.

   The Department has a compelling interest in the protection of the health, safety and welfare of the residents of this Commonwealth. Furthermore, the Department has a compelling interest in the reduction of the harmful effects, health concerns and complications which may be caused by unwanted and unplanned pregnancies which may result from sexual assaults. As drafted, the regulations are the least restrictive means of achieving these compelling interests as they reduce and even eliminate an objecting hospitals involvement in the provision of emergency contraception to sexual assault victims and allow hospitals to comply with these requirements by seeking the assistance of third-parties who can provide transportation for a victim to a location where emergency contraception could be obtained.

   One commentator requested the Department require hospitals operating under this exemption inform sexual assault victims verbally and in writing that it can arrange for a transfer of the victim, at no cost, to a facility that will provide emergency contraception. Other commentators suggested the hospitals should be required to inform the victims of their objections to emergency contraception immediately upon the victims presenting at the hospitals. The regulations have been revised to clearly indicate that a hospital is required to provide oral and written information to a victim of the availability of the arrangement for transportation. (See § 117.57(5).) A similar revision has been made to § 117.58. (See § 117.58(5).) The written emergency contraception materials created by the Department will also provide this information. Furthermore, it is important to allow the practitioners at a facility to make the appropriate assessment of each sexual assault victim and determine the timing of the services and treatment that will be provided. As detailed as follows, the Department has also revised the regulations to require prominent posting of the facility's exercise of the exemption. (See §§ 117.57(5) and 117.58(5)).

   One commentator suggested that if a victim cannot be transferred to a facility that will provide emergency contraception, the treating hospital should be required to provide emergency contraception notwithstanding any religious or moral belief to the contrary. The regulations require a hospital to ensure that all treatment is provided. If a hospital determines the extended treatment of a victim could result in a victim not receiving emergency contraception due to the hospital's religious or moral belief, the hospital should inform the victim and make arrangements to transfer the victim to a facility that will continue with any treatment required for the victim, including emergency contraception. If a hospital delays informing the victim of the availability of emergency contraception, or delays in arranging for transportation, until such time as emergency contraception would no longer be effective, the hospital may not be in compliance with the regulations.

   Another commentator suggested the Department address any conflict between § 117.57 and SB 990. At the end of the 2005-2006 Regular Session, SB 990 had failed to pass. On February 7, 2007, the Pennsylvania House referred House Bill 288 (HB 288), the Sexual Assault Victim Emergency Treatment Act, to the Health and Human Services Committee. Although similar to SB 990, HB 288 does not contain the religious exemption language that was included in SB 990. To date, no bill has been passed by the General Assembly regarding requirements for the provision of emergency contraception in hospitals in this Commonwealth. The Department will review these regulations periodically to determine their consistency with any subsequent legislation at either the State or Federal level which may provide for requirements similar to or related to those in these regulations.

   Some commentators, including IRRC, asked the Department to require a victim to be transferred to the ''closest'' hospital, not just a hospital in ''close proximity.'' Similar comments were made with regards to the transfer provision in § 117.58. The Department is cognizant of the possibility that in some areas, a hospital may exist which is not located in this Commonwealth but does provide the required services and is the closest hospital to where the victim is located. Further, in situations when other treatment has been provided and arrangements need only be made to ensure the victim receives emergency contraception, locations other than hospitals may be available. The Department has revised the regulations in light of these possibilities, including permitting transportation to out-of-State hospitals and to locations other than hospitals where emergency contraception is available.

   One commentator suggested hospitals operating under the exemptions in either this section or § 117.58 prominently post this information in the hospital's emergency services area so a sexual assault victim receives additional notice of the limitation of services provided by the hospital. IRRC agreed with this recommendation. The Department has revised the regulations to include prominent posting of notice in the hospital's emergency service areas. (See § 117.57(1).)

   Some commentators inquired as to applicability of the Emergency Medical Treatment and Active Labor Act (EMTALA) (42 U.S.C.A. § 1395dd) and related regulations at 42 CFR 489.24 (relating to special responsibilities of Medicare hospitals in emergency cases) to these regulations, and specifically to the exemptions and transfer provisions in this section and § 117.58. The Department notes that nothing in the regulations contradicts EMTALA or requires or allows a facility to violate the provisions of EMTALA. All hospitals which provide emergency services and are subject to EMTALA must provide the appropriate medical screening examinations and are required to treat or transfer sexual assault victims in accordance with the requirements of EMTALA. However, there is no indication that the Centers for Medicare and Medicaid Services (CMS) considers the provision of emergency contraception to be an emergency medical service which in itself would invoke the requirements of EMTALA. It should be noted that guidance issued by CMS provides that preventative care services (which, although not specific, could include medications to prevent pregnancy) and a request for gathering of evidence for criminal law cases (rape kits) are not considered, by CMS, to be medical care services under EMTALA, and do not invoke the provision of a medical screening examination under EMTALA. The implications of EMTALA on hospitals operating under the § 117.58 exemption present distinct issues which are addressed in the responses to comments to that section.

   Some commentators, including IRRC, inquired as to whether the Department required a transfer under § 117.57 be completed by an ambulance. The commentators also asked what authority the Department had to require a transfer by ambulance and who would be responsible for the cost. IRRC was also concerned about the cost of transporting victims for what may be considered nonemergency treatment. One commentator argued that requiring hospitals operating under the § 117.57 exemption to pay for the transfer would be a tax on the hospital for the exercise of their religious or moral beliefs.

   If a transfer by ambulance would be required under EMTALA or other applicable law, the Department would expect the applicable parties to comply with those laws. However, if current laws do not require transfer by ambulance for the purposes of obtaining emergency contraception, then these regulations should not be construed as a new requirement to do so. The Department is requiring a hospital operating under the exemption in § 117.57 to arrange for reasonable transportation for the victim. (See, § 117.57(2).) This can be accomplished in any one of various methods, including transfer by law enforcement, by a sexual assault counselor, or by a hospital transportation service. To avoid confusion, the Department has revised the regulations to eliminate the use of the word ''transfer'' in § 117.57 and replace it with ''transportation.''

   In response to the inquiry regarding payment for the transportation, the Department is only requiring that the victim not bear the cost of this transportation. Depending on the transportation arrangements made by the hospital, these costs could be covered by one of the programs available to cover the costs for sexual assault victims, or transportation could be provided by a rape crisis center who might not seek reimbursement for its services. It is not possible, therefore, to quantify these costs or determine a payer in the regulations.

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